Allergy Therapeutics Corporate Presentation - January 2016 - Proactive ...
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Allergy Therapeutics Corporate Presentation January 2016 Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director
Introduction We treat people with Allergic disorders Focused on the moderate to severe patients Providing treatments that cure the disease, not just treat symptoms Robust revenue growth and successful M&A delivered c.420 employees Spun-out from Smith Kline Beecham 1999 Headquarters and manufacturing base in Worthing, West Sussex AIM listed: ticker AGY Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 2
Strategy Strong European business European market share increased from 8.7% to 10.1% over last 2 years US opportunity Poised to execute a pivotal clinical trial programme to enable access to US – estimated $2bn market size New therapeutic areas Strong new product pipeline expanding the addressable markets: Peanut allergy- estimated $8bn market size House Dust Mite allergy- estimated $3bn market size Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 3
Global presence Sales and marketing network comprising c.120 European sales force UK Netherlands & Latvia, Estonia Canada Germany & Lithuania Poland Austria & Czech Switzerland Italy Republic & Slovakia Portugal Greece South Korea Spain Venezuela & Columbia Peru Subsidiaries Chile Argentina Distributors New Markets Subsidiaries in 9 countries and distribution agreements in additional 10 countries Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 4
Sales breakdown 1.Sales breakdown based on gross sales at budget exchange rates (before freight, discounts, rebates and exchange) : £49.3 million. After deducting discounts, rebates, freight charges and foreign exchange adjustments, total sales for FY2015 is £43.2 million Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 5
The Peanut Allergy Opportunity November 2015- exclusive right to develop Virus Like Particles (VLP) technology for allergy vaccines Carrier system to present allergens to the immune system First development will be for peanut allergy Currently no established and safe treatment available Commencing an R&D investment programme of c.£3m to progress the programme through to the start of Phase I trials over a 2-3 year period Peanut represents a new opportunity into the $8bn worldwide food allergy market Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 6
The US opportunity Immunotherapy is expected to grow at a CAGR of 11% to 2020* Estimated market: cost to payer $2 billion** Currently no registered injected products Clinical Development Plan for PQ Grass on track Opportunity fully funded Estimated launch 2019 Estimated peak grass sales US$300- US$400 million *Visiongain, AR forecast 2014 **Piper Jaffray Update on the AR market, Sept. 2008. Datamonitor Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 7
PQ product opportunity Current US SCIT market Allergy Therapeutics’ entry in the US • Home made preparation • Standardised dose vaccine • Non GMP manufacturing • GMP manufactured • Non registered • FDA submission planned in 2018 • No clinical evidence • Multiple clinical studies • Long courses of treatment: • Ultra- short course treatment: • 50 to 100 injections • 4 injections • Slow to act: 6 to 12 months • Efficacy in 3 weeks • Low compliance • High compliance Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 8
Keys to Success for PQ in the US Proprietary Technology IP Protected De-risked opportunity • Treated more than 250,000 patients and marketed in 7 countries Building on Progress to date in the US: • US$ 100 million invested in clinical studies to date • 14 clinical trials completed to date, including Phase I, II & III successful studies • Investigated in over 3,000 patients worldwide, mainly in the US Strategic fit for US market* • Pollinex Quattro is an injected product for an injected market First mover advantage • First to market in the seasonal injected segment • High entry barriers: regulatory requirements for extensive trials on efficacy and safety Source: *The Current States of Therapy for Allergic Rhinitis in the United States. Lawrence Du Buske, MD. Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 9
Competitive Landscape Four listed companies compete to lead the market in Europe and the US • ALK • Grastek: SLIT-Pill for grass allergy. Launched in the US • Ragwitek: SLIT-Pill for ragweed allergy. Launched in the US • Stallergenes • Oralair: SLIT-Pill for grass allergy. Launched in the US • Allergy Therapeutics • Pollinex Quattro: ultra-short SCIT for grass allergy. US launch expected in 2019 • Circassia • ToleroMune: ultra-short SCIT for cat allergy. In clinical development Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 10
2016 Expected News flow Q1 2016 US- PQ Grass 204- recruitment update 8 March Interims Q2 2016 Europe- PQ Birch 204- headline results Q2 2016 US- PQ Grass 204- headline results Q4 2016 US- Initiate G306 study recruitment Q4 2016 Europe- Clinical Trial Approval for PQ Birch 301 Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 11
Summary Immunotherapy is expected to be the fastest growing segment in the allergic rhinitis treatment market Raised £20m March 2015 (21p) to fund US opportunity for Pollinex Quattro Grass Planned launch in 2019 Raised £11m November 2015 (28p) to Accelerate core business growth Open peanut allergy opportunity • Strong trading in the first half of the financial year: +12% growth at constant currency We are delivering on all aspects of our growth strategy Proactive Investors 28th January 2016 – Ian Postlethwaite, Finance Director 12
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